Designed and built a Medical Device Quality Management System (QMS) as a personal project using Unifize. The system digitizes quality processes including Design Control, Non-Conformance (NC), CAPA, Supplier Quality, FMEA, SOP Training, and Customer Complaints. Built around ISO 13485 and FDA 21 CFR Part 820 concepts, the project demonstrates workflow design, process automation, role-based approvals, and AI-assisted documentation for regulated industries.